Mitral valve therapy device, system and method

ABSTRACT

An assembly and method for effecting the condition of a mitral valve annulus of a heart includes a guide wire configured to be fed into the coronary sinus of the heart, and a mitral valve annulus therapy device configured to be slidingly received on the guide wire and advanced into the coronary sinus of the heart on the guide wire. A guide tube may further be employed for guiding the device into the coronary sinus. An introducer which may be employed for pushing the device into or pulling device out of the heart has a mechanism for releasably locking to the device. This enables substitution of the device if needed. Also, the crossover point of the circumflex artery and coronary sinus may be determined and avoided when the device is deployed.

FIELD OF THE INVENTION

The present invention generally relates to a device, system and methodfor treating a deformed heart valve. The present invention moreparticularly relates to a device, system and method for constricting orreforming a mitral valve annulus from within the coronary sinus tocorrect mitral valve dilation without blocking blood flow in thecircumflex artery and which may be implemented using a guide wire withinthe coronary sinus to effect accurate device deployment andsubstitution.

BACKGROUND OF THE INVENTION

The human heart generally includes four valves. Of these valves, a mostcritical one.. is known as the mitral valve. The mitral valve is locatedin the left atrial ventricular opening between the left atrium and leftventricle. The mitral valve is intended to prevent regurgitation ofblood from the left ventricle into the left atrium when the leftventricle contracts. In preventing blood regurgitation the mitral valvemust be able to withstand considerable back pressure as the leftventricle contracts.

The valve cusps of the mitral valve are anchored to muscular wall of theheart by delicate but strong fibrous cords in order to support the cuspsduring left ventricular contraction. In a healthy mitral valve, thegeometry of the mitral valve ensures that the cusps overlie each otherto preclude regurgitation of the blood during left ventricularcontraction.

The normal functioning of the mitral valve in preventing regurgitationcan be impaired by dilated cardiomyopathy caused by disease or certainnatural defects. For example, certain diseases may cause dilation of themitral valve annulus. This can result in deformation of the mitral valvegeometry to cause ineffective closure of the mitral valve during leftventricular contraction. Such ineffective closure results in leakagethrough the mitral valve and regurgitation. Diseases such as bacterialinflammations of the heart or heart failure can cause the aforementioneddistortion or dilation of the mitral valve annulus. Needless to say,mitral valve regurgitation must not go uncorrected.

One method of repairing a mitral valve having impaired function is tocompletely replace the valve. This method has been found to beparticularly suitable for replacing a mitral valve when one of the cuspshas been severely damaged or deformed. While the replacement of theentire valve eliminates the immediate problem associated with a dilatedmitral valve annulus, presently available prosthetic heart valves do notpossess the same durability as natural heart valves.

Various other surgical procedures have been developed to correct thedeformation of the mitral valve annulus and thus retain the intactnatural heart valve function. These surgical techniques involverepairing the shape of the dilated or deformed valve annulus. Suchtechniques, generally known as annuloplasty, require surgicallyrestricting the valve annulus to minimize dilation. Here, a prosthesisis typically sutured about the base of the valve leaflets to reshape thevalve annulus and restrict the movement of the valve annulus during theopening and closing of the mitral valve.

Many different types of prostheses have been developed for use in suchsurgery. In general, prostheses are annular or partially annular shapedmembers which fit about the base of the valve annulus. The annular orpartially annular shaped members may be formed from a rigid material,such as a metal, or from a flexible material.

While the prior art methods mentioned above have been able to achievesome success in treating mitral regurgitation, they have not beenwithout problems and potential adverse consequences. For example, theseprocedures require open heart surgery. Such procedures are expensive,are extremely invasive requiring considerable recovery time, and posethe concomitant mortality risks associated with such procedures.Moreover, such open heart procedures are particularly stressful onpatients with a comprised cardiac condition. Given these factors, suchprocedures are often reserved as a last resort and hence are employedlate in the mitral regurgitation progression. Further, the effectivenessof such procedures is difficult to assess during the procedure and maynot be known until a much later time. Hence, the ability to makeadjustments to or changes in the prostheses to obtain optimumeffectiveness is extremely limited. Later corrections, if made at all,require still another open heart surgery.

An improved therapy to treat mitral regurgitation without resorting toopen heart surgery has recently been proposed. This is rendered possibleby the realization that the coronary sinus of a heart is near to and atleast partially encircles the mitral valve annulus and then extends intoa venous system including the great cardiac vein. As used herein, theterm “coronary sinus” is meant to refer to not only the coronary sinusitself but in addition, the venous system associated with the coronarysinus including the great cardiac vein. The therapy contemplates the useof a device introduced into the coronary sinus to reshape andadvantageously effect the geometry of the mitral valve annulus.

The device includes a resilient member having a cross sectionaldimension for being received within the coronary sinus of the heart anda longitudinal dimension having an unstressed arched configuration whenplaced in the coronary sinus. The device partially encircles and exertsan inward pressure on the mitral valve. The inward pressure constrictsthe mitral valve annulus or at least a portion of it to essentiallyrestore the mitral valve geometry. This promotes effective valve sealingaction and eliminates mitral regurgitation.

The device may be implanted in the coronary sinus using onlypercutaneous techniques similar to the techniques used to implantcardiac leads such as pacemaker leads. The device is implanted using anelongated introducer configured for being releasably coupled to thedevice. The introducer is preferably flexible to permit it to advancethe device into the heart and into the coronary sinus through thecoronary sinus ostium. To promote guidance, an elongated sheath is firstadvanced into the coronary sinus. Then, the device and introducer aremoved through a lumen of the sheath until the device is in positionwithin the coronary sinus. Because the device is formed of resilientmaterial, it conforms to the curvatures of the lumen as it is advancedthrough the sheath. The sheath is then partially retracted to permit thedevice to assume its unstressed arched configuration. Once the device isproperly positioned, the introducer is then decoupled from the deviceand retracted through the sheath. The procedure is then completed by theretraction of the sheath. As a result, the device is left within thecoronary sinus to exert the inward pressure on the mitral valve torestore mitral valve geometry.

The foregoing therapy has many advantages over the traditional openheart surgery approach. Since the device, system and method may beemployed in a comparatively noninvasive procedure, mitral valveregurgitation may be treated at an early stage in the mitralregurgitation progression. Further, the device may be placed withrelative ease by any minimally invasive cardiologist. Still further,since the heart remains completely intact throughout the procedure, theeffectiveness of the procedure may be readily determined. Moreover,should adjustments be deemed desirable, such adjustments may be madeduring the procedure and before the patient is sent to recovery.

Unfortunately, the human anatomy does impose some obstacles to thisrecently proposed procedure for treating mitral regurgitation. Morespecifically, the human heart includes a coronary artery which descendsfrom the aorta. One branch of the coronary artery is the circumflexartery which, in turn, includes the left marginal branch of thecircumflex artery. As used herein, the term “circumflex artery” is takento include the circumflex artery itself or any branch therefrom. Thecircumflex artery extends distally generally along the coronary sinusbut at a point proximal to the coronary artery, it passes under thecoronary sinus. The circumflex artery supports blood flow important tothe viability of the heart. Hence, reduction in this blood flow must beavoided. As a result, a device placed in the coronary sinus must not bepermitted to extend within the coronary sinus beyond the crossover pointof the circumflex artery and the coronary sinus to avoid constriction ofthe circumflex artery. This contemplates the need to know the locationof the circumflex artery and coronary sinus crossover point. It alsocontemplates accurate positioning of the device within the coronarysinus to assure that the device does not extend over the circumflexartery.

The above is further compounded by the fact that the human heart anatomyand indeed the mitral valve condition will vary from patient to patient.Hence, after deployment of an initial therapy device, the initial deviceeffectiveness must be tested. Should a further device having differentproperties or configuration be deemed more efficacious, there must beprovided a way to easily remove the initial device and then deploy thefurther device with the same deployment accuracy to avoid the crossoverof the circumflex artery with the coronary sinus.

The present invention addresses these issues. The present inventionprovides a therapy system and procedure which enables avoidance of thecrossover of the circumflex artery with the coronary sinus by permittingaccurate placement of an initial device or any substitute device withinthe coronary sinus. Further to that end, the present invention enablesthe crossover point of the circumflex artery with the coronary sinus tobe readily determined and, if desired, continuously observed during thetherapy procedure. Still further, the present invention contemplates amitral valve therapy device which is configured to avoid constrictingthe circumflex artery even though it passes over the circumflex arterywithin the coronary sinus.

SUMMARY OF THE INVENTION

The present invention provides an assembly for effecting the conditionof a mitral valve annulus of a heart. The assembly includes a guide wireconfigured to be fed into the coronary sinus of the heart and a mitralvalve annulus therapy device configured to be slidably received on theguide wire and advanced into the coronary sinus of the heart on theguide wire.

The assembly may further include an elongated introducer configured tobe slidingly received on the guide wire proximal to the device. Theintroducer may be releasably locked to the device during the deploymentof the device within the coronary sinus. The assembly may furtherinclude a guide tube having an inner lumen dimensioned for receiving theguide wire and the device and introducer when the device and introducerare slidingly received on the guide wire.

The assembly may still further include an elongated flexible memberwhich is visible under X ray fluoroscopy and which may be advanced intothe circumflex artery. The guide wire may also be visible under X rayfluoroscopy to reveal, under X ray fluoroscopic examination, thecrossover point of the circumflex artery and the coronary sinus.

The present invention still further provides a mitral valve annulusdevice for reshaping the mitral valve annulus to effect the condition ofa mitral valve annulus of a heart. The device includes a resilientmember having a cross sectional dimension for being received within thecoronary sinus of a heart and having a longitudinal dimension having anarched configuration for partially encircling the mitral valve andexerting an inward pressure on the mitral valve when within the coronarysinus adjacent the mitral valve for reshaping at least a portion of themitral valve annulus. The device includes a distal end having a bentportion to avoid exerting pressure on the circumflex artery at thecrossover point of the circumflex artery and the coronary sinus.

The present invention further provides a mitral valve annulus therapydevice including a generally C-shaped clip member formed of resilientmaterial for exerting a substantially radially inward force on themitral valve annulus when placed in the coronary sinus of a heart aboutand adjacent to the mitral valve. The device has a distal end includinga bent portion to avoid exerting pressure on the circumflex artery atthe crossover point of the circumflex artery and the coronary sinus.

The present invention further provides a method of determining thecrossover point of the circumflex artery and coronary sinus of a heart.The method includes the steps of inserting a first elongated flexiblerod into the coronary sinus, the first rod being visible under X rayfluoroscopy, inserting a second elongated flexible rod into thecircumflex artery, the second rod being visible under X ray fluoroscopy,and subjecting the heart to X ray fluoroscopic examination to determinethe crossover point of the first and second rods.

The present invention further provides a method of deploying a mitralvalve annulus reshaping device within the coronary sinus of a heart. Themethod includes the steps of inserting a guide wire into the coronarysinus of the heart, and advancing an elongated mitral valve annulusconstricting device on the guide wire and into the coronary sinus into aposition such that the device at least partially encircles the mitralvalve of the heart.

The advancing step may further include the steps of slidingly mountingan elongated flexible introducer onto the guide wire proximal to thedevice, engaging the distal end of the introducer with the proximal endof the device, and pushing the device distally into the coronary sinuswith the introducer. After the device is deployed in the coronary sinus,the introducer may be withdrawn.

During deployment of the device, the introducer may be releasably lockedto the device. After deployment, but before the introducer is withdrawn,the introducer may be released from the device.

The method may further include the steps of providing an elongatedflexible guide tube having an inner lumen, the inner lumen having across sectional dimension greater than the cross sectional dimension ofthe guide wire, and feeding the guide tube into the coronary sinus ofthe heart over the guide wire with the guide wire within the inner lumenof the guide tube. Thereafter, the device may be pushed along the guidewire and within the guide tube.

The present invention further provides a method of deploying a mitralvalve annulus therapy device within the coronary sinus of a heart. Themethod includes the steps of inserting a first wire into the circumflexartery of the heart, the first wire being visible under X rayfluoroscopy, inserting a second wire into the coronary sinus of theheart, the second wire being visible under X ray fluoroscopy, subjectingthe heart to X ray fluoroscopic examination to visualize the crossoverpoint of the first and second wires, and deploying an elongated mitralvalve annulus therapy device within the coronary sinus in a positionsuch that the distal end of the device is proximal to the crossoverpoint of the first and second wires. Preferably, during deployment, thedevice is guided by the second wire into the coronary sinus.

The method may further include the steps of slidingly mounting anelongated flexible introducer onto the second wire proximal to thedevice, engaging the distal end of the introducer with the proximal endof the device, and pushing the device distally into the coronary sinuswith the introducer. During deployment, the introducer may be releasablylocked to the device. After deployment, the introducer may be releasedfrom the device and withdrawn.

The method may further include the steps of providing an elongatedflexible guide tube having an inner lumen, the inner lumen having across sectional dimension greater than the cross sectional dimension ofthe second wire, and the guide tube being transparent to X rayfluoroscopy, and feeding the guide tube into the coronary sinus of theheart over the second wire with the second wire within the inner lumenof the guide tube. The device may then be pushed along the second wireby the introducer and within the guide tube until it reaches a desiredposition within the coronary sinus.

The present invention still further provides a method of deploying aconstricting device within the coronary sinus of a heart to reshape themitral valve annulus of the heart. The method includes the steps ofproviding an elongated flexible guide wire having a cross sectionaldimension, feeding the guide wire into the coronary sinus of the heart,providing an elongated flexible guide tube having an inner lumen, theinner lumen having a cross sectional dimension greater than the crosssectional dimension of the guide wire, and feeding the guide tube intothe coronary sinus of the heart over the guide wire with the guide wirewithin the inner lumen of the guide tube.

The method further includes the steps of providing a mitral valveannulus constricting device configured to be slidingly received on theguide wire and within the inner lumen of the guide tube, the deviceincluding a proximal end, providing a flexible elongated introducerconfigured to be slidingly received on the guide wire and within theinner lumen of the guide tube, the introducer having a distal end, andplacing the device onto the guide wire.

The method still further includes the steps of placing the introduceronto the guide wire, engaging the distal end of the introducer with theproximal end of the device, pushing the device with the introducer in adistal direction along the guide wire and within the guide tube untilthe device is at least partially encircling the mitral valve within thecoronary sinus of the heart, and withdrawing the introducer and theguide tube from the heart.

During deployment of the device, the introducer may be releasably lockedto the device. After deployment, but before the introducer is withdrawn,the introducer may be released from the device. The effectiveness of thedevice may then be tested.

Should a replacement device be required, further steps to replace thedevice with a substitute device may be taken. Those steps may includefeeding the guide tube into the coronary sinus of the heart over theguide wire and the device, feeding the introducer over the guide wireand into the guide tube, releasably locking the distal end of theintroducer to the proximal end of the device, and retracting theintroducer and device in a proximal direction and from the guide tube.When the device has been removed, a replacement device may then bedeployed in the same manner as the initial device was deployed.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel areset forth with particularity in the appended claims. The invention,together with further aspects and advantages thereof, may best beunderstood by making reference to the following description taken inconjunction with the accompanying drawings, and the several figures ofwhich like reference numerals identify identical elements, and wherein:

FIG. 1 is a superior view of a human heart with the atria removed;

FIG. 2 is a perspective view of a mitral valve annulus constrictingdevice embodying the present invention;

FIG. 3 is a perspective view of an assembly for deploying a mitral valveconstricting device in accordance with a preferred embodiment of thepresent invention;

FIG. 4 is another perspective view of the assembly of FIG. 3;

FIG. 5 is a superior view of a human heart similar to that of FIG. 1 andillustrating a method of determining the crossover point of thecircumflex artery and the coronary sinus in accordance with a preferredembodiment of the present invention;

FIG. 6 is another view of a human heart illustrating the method ofdetermining the crossover point of the circumflex artery and thecoronary sinus in accordance with the present invention;

FIG. 7 is another superior view of a human heart illustrating deploymentof a mitral valve therapy device in accordance with the preferredembodiment of the present invention;

FIG. 8 is another superior view of a human heart illustrating animplanted mitral valve therapy device embodying the present invention;

FIG. 9 is another superior view of a human heart illustrating anothermitral valve therapy device embodying the present invention implanted inthe heart;

FIG. 10 is a perspective view of another mitral valve annulus deviceembodying the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to FIG. 1, it is a superior view of a human heart 10 withthe atria removed to expose the mitral valve 12, the coronary sinus 14,the coronary artery 15, and the circumflex artery 17 of the heart 10 tolend a better understanding of the present invention. Also generallyshown in FIG. 1 are the pulmonary valve 22, the aortic valve 24, and thetricuspid valve 26 of the heart 10.

The mitral valve 12 includes an anterior cusp 16, a posterior cusp 18and an annulus 20. The annulus encircles the cusps 16 and 18 andmaintains their spacing to provide a complete closure during a leftventricular contraction. As is well known, the coronary sinus 14partially encircles the mitral valve 12 adjacent to the mitral valveannulus 20. As is also known, the coronary sinus is part of the venussystem of the heart and extends along the AV groove between the leftatrium and the left ventricle. This places the coronary sinusessentially within the same plane as the mitral valve annulus making thecoronary sinus available for placement of the mitral valve therapydevice of the present invention therein.

Of particular importance is the physiological relationship of thecoronary sinus 14 and the circumflex artery 17. The circumflex artery 17branches from the coronary artery 15 and supplies blood flow to criticaltissue of the heart 10. The circumflex artery passes beneath thecoronary sinus 14 at a crossover point 19. It is one aspect of thepresent invention to avoid constriction of blood flow through thecircumflex artery 17 when a mitral valve therapy device is deployed inthe coronary sinus 14.

FIG. 2 shows a mitral valve therapy device 30 embodying the presentinvention. As may be noted in FIG. 2, the device is elongated and has anarched configuration to at least partially encircle the mitral valve 12adjacent to the mitral valve annulus 20 when implanted in the coronarysinus 14. The device 30 has an unstressed preformed arched radiussmaller than the radius of the dilated mitral valve annulus 20. Thiscauses the device 30 to constrict the mitral valve annulus and impart aninward, generally radial force designated by arrows 32 on the mitralvalve annulus 20 when implanted in the coronary sinus of the heart. Thisforce reshapes and returns the mitral valve annulus 20 to its originalor substantially original geometry to permit the cusps 16 and 18 to morefully come together for sealing the left atrium during left ventricularcontraction.

The device 30 has a cross section dimension to be received by thecoronary sinus. It is preferably formed of a resilient materialpermitting the device to be straightened and/or bent for being advancedinto the coronary sinus. After being positioned within the coronarysinus, the device is permitted to assume its preformed archedconfiguration to act upon the mitral valve annulus as previouslydescribed. To that end, the device may be formed of, for example,Nitinol, a nickel titanium alloy, well known in the art. This material,as is well known, is capable of being preformed but manipulated to bestraight or partially bent while having sufficient memory to return toits preformed configuration. Stainless steel is also among the materialswhich may be used in forming the device 30. In order to be receivedwithin the coronary sinus, the device may have a cross sectionaldimension of, for example, on the order of four or five french.

With continued reference to FIG. 2, the device 30 has a distal end 34and a proximal end 36. Between the distal end 34 and proximal end 36 thedevice further includes a channel 38 which is aligned with a bore 40extending through the distal end 34 and a bore 42 extending through theproximal end 36. The proximal end 36 further includes an integral sleeve44 which carries a protruding locking pin 46. As will be seensubsequently, the bores 40 and 42 permit the device to be slidinglyreceived by a guide wire during deployment of the device 30. The guidewire, during deployment, is confined within the channel 38.

FIGS. 3 and 4. illustrate an assembly 50 for deploying or implanting themitral valve therapy device 30. The assembly 50 includes a guide wire52, a guide tube 54, and an elongated introducer 56.

The guide wire 52 is preferably an elongated coil. It has an outerdimension to permit the guide wire 52 to be passed through the bores 40and 42 of the device 30. This enables the device 30 to be slidinglyreceived on the guide wire 52 with the guide wire confined within thechannel 38 of the device 30.

The guide tube 54 is elongated and formed of a flexible biocompatiblematerial. It includes an inner lumen 55 permitting the device 30 and theintroducer 56 to be received therein.

The introducer 56 preferably takes the form of an elongated coil havingan inner channel dimensioned to be received by and slid onto the guidewire 52. At a distal end 58 the introducer includes a sleeve 60 whichmay be received over the sleeve 44 of the device 30. The introducersleeve 60 includes a detented slot 62 for releasably receiving the pin46 of the device 30. This enables the introducer 56 to be releasablylocked to the device 30 during deployment of the device. It also permitsthe introducer to be relocked to the device 30 for extracting the deviceshould it be necessary to remove the device 30 for exchange with anotherdevice.

As previously mentioned, the circumflex artery 17 passes under thecoronary sinus 14. When the device 30 is deployed, it should not bepermitted to exert a force from the coronary sinus against thecircumflex artery. Hence, in accordance with one embodiment of thepresent invention, the device is implanted within the coronary sinus ata position whereby the distal end 34 of the device 30 is proximal to thecrossover point of the circumflex artery and the coronary sinus. Thisrequires determination of the crossover point. FIGS. 5 and 6 illustratehow such a determination may be made in accordance with the presentinvention.

A first elongated member, such as an elongated wire or coil wire 70 isinserted into the circumflex artery 17. The wire 70 may be formed of amaterial visible under X ray fluoroscopy or be of other material havinga coating which is visible under X ray fluoroscopy. Next, a second wirewhich may be the guide wire 52 is inserted into the coronary sinus 14 byway of the ostium of coronary sinus 13. Again, the wire 52 is preferablyof a material visible under X ray fluoroscopy or of another materialhaving a coating which is visible under X ray fluoroscopy. Preferably,the wires 52 and 70 are elongated coils formed of stainless steel.

The heart 10 or at least that portion of the heart 10 where thecircumflex artery passes under the coronary sinus is subjected to X rayfluoroscopy. X ray fluoroscopy is well known in the art. The crossoverpoint 19 where the wires 52 and 70 cross and hence where the circumflexartery and coronary sinus cross may then be readily observed by X rayfluoroscopic examination. This locates the crossover point 19 which isto be distal to the distal end 34 of the device 30 when the device 30 ispositioned within the coronary sinus.

Once the crossover point 19 has been determined, the device 30 may bedeployed. During the deployment of the device, the first wire 70 may beleft in the circumflex artery to permit continuous X ray fluoroscopicexamination or later X ray fluoroscopic examination to confirm properdevice positioning.

FIG. 7 shows how the assembly 50 may be used to implant the device 30.Presumably the guide wire 52 has already been positioned in the coronarysinus 14 to support the determination of the circumflex artery andcoronary sinus crossover point as described above. As also describedabove, wire 70 may also be left in the heart at this time.

Next, the guide tube 54 is advanced into the heart. The guide tube isadvanced over the guide wire 52. The guide wire hence guides the guidetube 54 into the coronary sinus where the device is to be implanted.

When the guide tube 54 is positioned in the coronary sinus, the device30 and introducer 56 are then advanced into the guide tube 54 and overthe guide wire 52. The distal end 58 of the introducer 56 is firstreleasably locked to the proximal end 36 of the device 30 (FIGS. 3 and4) by advancing the sleeve 60 of the introducer 56 over the sleeve 44 ofthe device 30 and inserting the locking pin 46 in the detented lockinggroove 62.

With the distal end of the introducer 56 thus engaged with the proximalend of the device 30, the device may then be pushed by the introducer 56into the coronary sinus 14 while being guided by both the guide wire 52and the guide tube 54.

When the device is positioned within the coronary sinus 14 with itsdistal end proximal to the crossover point 19 and its position isconfirmed by X ray fluoroscopy, the introducer may be removed. This isaccomplished by turning the introducer to unlock the pin 46 andretracting the introducer from the guide tube. Then, the guide tube 54may also be retracted leaving the device in place but still on the guidewire 52. The performance of the device 30 may now be evaluated. Ifanother device of different properties is deemed more appropriate, thedevice may be readily replaced. Thus is accomplished by reinserting theguide tube over the device, reinserting the introducer, locking theintroducer to the device, and removing the device through the guide tubewith the introducer. A new device may then be deployed as previouslydescribed.

Once a device is deployed that satisfies the requirements of theprocedure, the guide wire 52, and the wire 70 if still within the heart,may be removed. This leaves the device 30 in its proper position asillustrated in FIG. 8. Here it may be seen that the device 30 partiallyencircles the mitral valve 12 within the coronary sinus 14 and adjacentto the mitral valve annulus. The distal end 34 of the device 30 isproximal to the crossover point 19. The proximal end 36 of the deviceprotrudes slightly into the right atrium (not shown) through the ostiumof coronary sinus 13. The sleeve 44 and pin 46 remain should subsequentremoval of the device be deemed necessary.

FIG. 9 shows another mitral valve therapy device 130 embodying thepresent invention. As may be noted in FIG. 9, the device is elongatedand has an arched configuration to at least partially encircle themitral valve 12 adjacent to the mitral valve annulus 20 when implantedin the coronary sinus 14. The device 130 has an unstressed preformedarched radius smaller than the radius of the dilated mitral valveannulus 20 to impart an inward, generally radial force when implanted inthe coronary sinus of the heart as shown. This force again returns themitral valve annulus 20 to its original or substantially originalgeometry to permit the cusps 16 and 18 to more fully come together forsealing the left atrium during left ventricular contraction.

The device 130 has a cross sectional dimension to be received by thecoronary sinus. It is also preferably formed of a resilient material topermit the device to be straightened and/or bent for being advanced intothe coronary sinus. After being positioned within the coronary sinus,the device is permitted to assume its preformed arched configuration toact upon the mitral valve annulus as previously described. To that end,the device may be formed of, for example, Nitinol, a nickel titaniumalloy.

The device 130 has a distal end 134 and a proximal end 136. Between thedistal end 134 and proximal end 136 the device further includes achannel 138 which is aligned with a bore 140 extending through thedistal end 134 and a bore 142 extending through the proximal end 136.The proximal end 136 further includes an integral sleeve 144 whichcarries a protruding locking pin 146. Again, the bores 140 and 142permit the device to be slidingly received by a guide wire duringdeployment of the device 130. The guide wire, during deployment, isconfined within the channel 138.

The device 130 still further includes a bend 50 at its distal end 134.As will be noted, the distal end 134 extends beyond the crossover point19 of the circumflex artery 17 and the coronary sinus 14. However,because of the bend 150, the device is precluded from exertingconstricting pressure on the circumflex artery 17 even though it extendsover the crossover point 19. The device 130 may be implanted using theassembly as previously described.

FIG. 10 shows still another mitral valve therapy device 230 embodyingthe present invention. Like the device 30 of FIG. 2, the device 230 iselongated and has an arched configuration to at least partially encirclethe mitral valve 12 adjacent to the mitral valve annulus 20 whenimplanted in the coronary sinus 14. The device 230 has an unstressedpreformed arched radius smaller than the radius of the dilated mitralvalve annulus 20 to impart an inward, generally radial force on themitral valve annulus 20 when implanted in the coronary sinus of theheart to return the mitral valve annulus 20 to its original orsubstantially original geometry permitting the cusps of the mitral valveto more fully come together for sealing the left atrium during leftventricular contraction.

The device 230 has a cross section dimension to be received by thecoronary sinus. It is preferably formed of any of the resilientmaterials previously described.

The device 230 has a distal end 234 and a proximal end 236. Between thedistal end 234 and proximal end 236 the device further includes achannel 238 which is aligned with a bore 242 extending through theproximal end 236. The proximal end 236 further includes an integralsleeve 244 which carries a protruding locking pin 246. The bore 242permits the device to be slidingly received by the guide wire duringdeployment of the device 230. The guide wire, during deployment, isconfined within the channel 238. The assembly 50 of FIGS. 3 and 4including the guide wire 52, guide tube 54, and elongated introducer 56may be utilized as described for deploying the device 230. Here,however, only one end of the device need be slidingly received by theguide wire 52 since the device is well confined within the guide tube 54and the guide wire 52 is confined within the channel 238.

As can thus be seen from the foregoing, the present invention provides anew and improved device, assembly and method for treating mitralregurgitation. The device may be employed with only percutaneoustechniques. Further, the mitral valve therapy device may be implanted ina manner which avoids the crossover point of the circumflex artery andcoronary sinus. Lastly, the effectiveness of the therapy may beimmediately deduced during the implant procedure and permitssubstitution of devices for optimized results.

While particular embodiments of the present invention have been shownand described, modifications may be made, and it is therefore intendedin the appended claims to cover all such changes and modifications whichfall within the true spirit and scope of the invention.

1.-15. (Canceled)
 16. A method of deploying a mitral valve annulusconstricting device within the coronary sinus of a heart, the methodincluding the steps of: A. providing an elongated flexible guide wirehaving a cross sectional dimension; B. feeding the guide wire into thecoronary sinus of the heart; C. providing an elongated flexible guidetube having an inner lumen, the inner lumen having a cross sectionaldimension greater than the cross sectional dimension of the guide wire;D. feeding the guide tube into the coronary sinus of the heart over theguide wire with the guide wire within the inner lumen of the guide tube;E. providing a mitral valve annulus device configured to be slidinglyreceived on the guide wire and within the inner lumen of the guide tube,the device including a proximal end; F. providing a flexible elongatedintroducer configured to be slidingly received on the guide wire andwithin the inner lumen of the guide tube, the introducer having a distalend; G. placing the device onto the guide wire; H. placing theintroducer onto the guide wire; I. engaging the distal end of theintroducer with the proximal end of the device, the engaging stepincluding releasably locking the proximal end of the device to thedistal end of the introducer; J. pushing the device with the introducerin a distal direction along the guide wire and within the guide tubeuntil the device is at least partially encircling the mitral valvewithin the coronary sinus of the heart; and K. withdrawing theintroducer and the guide tube from the heart:
 17. (Canceled)
 18. Themethod of claim 16 including the further step J(1) of releasing theproximal end of the device from the distal end of the introducer priorto withdrawing the introducer.
 19. The method of claim 18 including thefurther step L of testing the effectiveness of the device after thewithdrawing step.
 20. The method of claim 19 including the further stepsof replacing the device with a further device, the replacing stepsincluding: feeding the guide tube into the coronary sinus of the heartover the guide wire and the device; feeding the introducer over theguide wire and into the guide tube; releasably locking the distal end ofthe introducer to the proximal end of the device in a proximal directionand from the guide tube; and repeating steps E and G through L with afurther device. 21.-30. (Canceled)
 31. A method of deploying a mitralvalve annulus reshaping device within the coronary sinus of a heart, themethod including the steps of: inserting a guide wire into the coronarysinus of the heart; deforming the mitral valve annulus reshaping devicefrom an unstressed shape having a radius smaller than the radius of amitral valve annulus of the heart to a deformed shape; and advancing themitral valve annulus reshaping device on the guide wire and into thecoronary sinus into a position such that the device at least partiallyencircles the mitral valve of the heart.
 32. The method of claim 31wherein the advancing step further includes the steps of slidinglymounting an elongated flexible introducer onto the guide wire proximalto the device, engaging the distal end of the introducer with theproximal end of the device, and pushing the device distally into thecoronary sinus with the introducer.
 33. The method of claim 32 includingthe further step of withdrawing the introducer after deploying thedevice.
 34. The method of claim 33 wherein the engaging step includesreleasably locking the proximal end of the device to the distal end ofthe introducer.
 35. The method of claim 34 including the further step ofreleasing the proximal end of the device from the distal end of theintroducer prior to withdrawing the introducer.
 36. The method of claim32 including the further steps of: providing an elongated flexible guidetube having an inner lumen, the inner lumen having a cross sectionaldimension greater than the cross sectional dimension of the guide wire;feeding the guide tube into the coronary sinus of the heart over theguide wire with the guide wire within the inner lumen of the guide tube;and wherein the pushing step includes pushing the device along the guidewire and within the guide tube.
 37. The method of claim 36 wherein theengaging step includes releasably locking the proximal end of the deviceto the distal end of the introducer.
 38. The method of claim 37including the further steps of releasing the proximal end of the devicefrom the distal end of the introducer and withdrawing the introducer andthe guide tube after deploying the device. 39.-57. (Canceled)